Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion
- Conditions
- Healthy
- Interventions
- Behavioral: Lipids infusionBehavioral: Sham infusion
- Registration Number
- NCT04938934
- Brief Summary
Meal ingestion induces sensations that are influenced by a series of conditioning factors.
Aim: to determine the conditioning effect of previous digestive symptoms to a standardized probe meal.
Controlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).
Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- non-obese
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aversive conditioning Lipids infusion - Sham conditioning Sham infusion -
- Primary Outcome Measures
Name Time Method Difference in digestive well-being in response to a comfort meal before and after conditioning. 120 minutes Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a comfort meal before and after conditioning.
- Secondary Outcome Measures
Name Time Method Change in mood in response to a comfort meal before and after conditioning 120 minutes Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a comfort meal before and after conditioning.
Change in hunger/satiety in response to a comfort meal before and after conditioning 120 minutes Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a comfort meal before and after conditioning
Difference in fullness sensation in response to a comfort meal before and after conditioning 120 minutes Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning.
Change in discomfort in response to a comfort meal before and after conditioning 120 minutes Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning
Trial Locations
- Locations (1)
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain